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Blood filter device tested to fight COVID-19 organ failure

NCT ID NCT04547257

Disease control Sponsor: ExThera Medical Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This trial tests a device called Seraph 100, a blood filter used to treat severe COVID-19. The goal is to see if filtering the blood can reduce organ failure in patients with COVID-19 who are in the intensive care unit. The study enrolled 42 adults with confirmed COVID-19 and organ problems. Researchers measure changes in organ function over 48 hours and track survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Seraph 100 blood filter
What this could lead to
If it works, this could provide a new way to treat severe COVID-19 by filtering harmful substances from the blood, potentially reducing organ failure and improving survival.
What could go wrong
This is a small early study with only 42 participants, so results may not apply to everyone. The device is experimental and may not improve outcomes or could cause complications from the filtering process.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 42 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2021

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 90 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Subjects with confirmed SARS-CoV-2 infection 2. Be ≥ 18 years old and ≤90 years old 3. Acute respiratory distress syndrome assessed by a modified Sequential Organ Failure Assessment score of at least 2 points 4. At least one additional organ dysfunction assessed by a modified Sequential Organ Failure Assessment score of at least 1 point 5. Written or electronic consent of the subjects who are legally competent and have the capacity to give consent Exclusion Criteria: 1. Subject is currently participating in another clinical investigation 2. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period 3. Presence of comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results 4. Have Child-Pugh Class C cirrhosis 5. Have platelet count \<30.000/uL 6. Contraindications for heparin sodium for injection 7. Subjects demonstrating any contraindication for this treatment as described in the IFU 8. Subjects with known allergy of polyethylene and copolyester 9. Subjects with hospital-acquired SARS-CoV-2 infections 10. Subject is held in an institution by court or official order 11. Subject is dependent on the sponsor or investigator so that consent can no longer be considered voluntary

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Conditions

The condition(s) this trial relates to.

COVID-19

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

COVID-19

Contacts and locations

Locations

  • Hospital Clinico San Carlos

    Madrid, 28040, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Klinikum Aschaffenburg-Alzenau

    Aschaffenburg, 63739, Germany

  • Universitätsklinikum Essen

    Essen, 45147, Germany

  • Vivantes Klinikum Neukölln

    Berlin, 12351, Germany

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